NCT05341817 The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy
| NCT ID | NCT05341817 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Abortion in First Trimester |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 144 participants in total. It began in 2022-11-22 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Medical termination of pregnancy (mTOP) generally involves using either a combined regimen consisting of mifepristone and misoprostol, or a misoprostol-only regimen. Complete abortion rates of first trimester mTOP with the use of misoprostol-only regimen varies between 74-88%. With the addition of mifepristone as pre-treatment drug, this improves success rates to 93-97%. Mifepristone, an anti-progesterone, is relatively expensive and is subject to stringent regulations for usage in addition to restricted access in many countries. Therefore, there is a need to find a cheaper and more readily available, yet effective alternative. The use of letrozole (an aromatase inhibitor) in mTOP is postulated to suppress estradiol levels (an important factor in the maintenance of early pregnancy), therefore enhancing the effect of misoprostol in inducing abortion. Studies have shown that pre-treatment with letrozole achieves a complete abortion rate of 77-98%, similar to that in mifepristone-Misoprostol studies. The investigators hypothesise that letrozole is equivalent to mifepristone for the pre-treatment of mTOP and propose to conduct a randomised, non-inferiority trial for mTOP up to 10 weeks gestation with two arms as detailed below: 1. Oral letrozole 10mg daily for 3 days, followed by vaginal misoprostol on Day 3 (Intervention group) 2. Oral mifepristone 200mg once on Day 1, followed by vaginal misoprostol 800mcg on Day 3. Then, 4 hours later, another dose of 400mcg PV misoprostol if no signs of abortion (Control group - current practice). The investigators aim to include a total of 144 patients, 72 in each arm, to detect a non-inferiority margin of 15% with a power of 80% at 5% significance. The investigators primary outcome will be rate of complete abortion by Day 21-28 of mTOP. This pilot RCT will provide preliminary data and preparation for larger grant application which will provide necessary evidence to enhance the care of women undergoing mTOP, with enhanced cost-savings and availability.
Eligibility Criteria
Inclusion Criteria: * 21 years and above * Patient requesting for medical termination of pregnancy (mTOP) * Patient eligible for legal abortion according to the Termination of Pregnancy Act (Chapter 324) * Gestational age ≤10 weeks (on day 1 of mifepristone or letrozole administration) as confirmed by the first trimester dating scan * Singleton pregnancy * Patient is agreeable to undergo surgical evacuation or repeat medical therapy if treatment fails * Willing and able to provide written, informed consent Exclusion Criteria: * History or evidence of adrenal pathology, steroid-dependent cancer, porphyria, poorly controlled hypertension, bronchial asthma, thromboembolism and severe cardiac/renal/liver disease * Haemoglobin level of \<9.5 g/L * Presence of an intrauterine contraceptive device * Breastfeeding * Reported allergic reaction to mifepristone, misoprostol or letrozole, * Participating in another trial of investigational medicinal products during the current pregnancy
Contact & Investigator
Meei Jiun Seet
PRINCIPAL INVESTIGATOR
Consultant at KK Women&#39;s and Children&#39;s Hospital, Singapore
Frequently Asked Questions
Who can join the NCT05341817 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Abortion in First Trimester. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05341817 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05341817 currently recruiting?
Yes, NCT05341817 is actively recruiting participants. Contact the research team at julin.wong.sx@kkh.com.sg for enrollment information.
Where is the NCT05341817 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05341817 clinical trial?
NCT05341817 is sponsored by KK Women's and Children's Hospital. The principal investigator is Meei Jiun Seet at Consultant at KK Women&#39;s and Children&#39;s Hospital, Singapore. The trial plans to enroll 144 participants.